Evaluating the Effectiveness of Pterocarpus santalinus (Sandalwood) Bark Extract in Managing Tension-Type Headaches: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Abstract

Background: Tension-type headache (TTH) is the most prevalent primary headache disorder worldwide and a major cause of disability. Despite its burden, current pharmacologic options have limited efficacy and tolerability, prompting exploration of safe, plant-based alternatives. Pterocarpus santalinus bark extract possesses antioxidant and anti-inflammatory properties that may mitigate both peripheral and central mechanisms of pain sensitization. Objective: To evaluate the effectiveness of Pterocarpus santalinus bark (PSB) extract in reducing pain intensity and frequency among patients with tension-type headache. Methods: A pragmatic, randomized, double-blind, placebo-controlled, multicenter clinical trial was conducted in Lahore, Pakistan, enrolling 80 adults aged 18–65 years diagnosed with TTH. Participants were randomly allocated (1:1) to receive either PSB extract (100 mg/mL, 250 mL three times daily) or placebo for one week. The primary outcome was change in Visual Analogue Scale (VAS) pain score, analyzed using repeated-measures ANOVA. Results: Baseline characteristics were comparable between groups. The PSB group showed a significant reduction in mean VAS scores from 6.22 ± 1.03 to 0.48 ± 0.51, compared to 6.10 ± 1.09 to 4.05 ± 1.01 in the placebo group (p < 0.001). Effect sizes were large (Cohen’s d > 2), and 95% achieved complete pain relief. No adverse events were reported. Conclusion: Pterocarpus santalinus bark extract provides rapid, sustained, and well-tolerated analgesia in TTH, supporting its potential as a safe herbal adjunct to conventional therapy.